Effect of Superstarch on Soccer PerformanceNCT02667340
Superstarch and Physical/Cognitive Performance Following a Simulated Soccer Game
A study testing Superstarch in people with Effect of Superstarch on Soccer Performance, run by University of Western Ontario, Canada.
Trial summary
To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of specific soccer skills, and on cognitive function during and following a simulated soccer game. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Superstarch on Soccer Performance
- What is being tested?
- Superstarch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy male and female elite soccer players who are involved in regular soccer training
- aged 15-35 years
Who cannot join
- Smoker
- taking part in other research
- have a neurological or psychiatric condition that may cause cognitive dysfunction
- for women, if they are pregnant or become pregnant during the study
- Injury limiting exercise ability
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Starch Produced From Heat-treated Corn (Superstarch) Supplementation on Skills, Cognitive Function and Physical Performance During/Following a Simulated Soccer Game
To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of specific soccer skills, and on cognitive function during and following a simulated soccer game.
Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during the game with Generation UCAN vs isoenergetic placebo (glucose).
Read the detailed description
This will be a double blind cross over study. There will be two treatments involved: Superstarch and glucose (placebo). Participants and investigators will be blinded as an individual not involved in the project will prepare and distribute the treatment (drinks) according to a coding system that is kept confidential until the study is completed. Participants will complete each treatment once and the treatment order will be systematically rotated to avoid any order effect. Healthy men and women soccer players aged 18-35 yr will be recruited. Participants will come to the lab on five different occasions to complete two familiarization sessions, a baseline testing session, and two main trials. During the first visit, the participants will be asked to complete a physical activity readiness questionnaire (as approved previously; Par Q and a participant information form for personal and familial health history to rule out any pathologies or health issues that may preclude them from participating in the present study. Subsequently, the investigators will collect data for VO2max, body composition and sprinting speed. In the second visit, participants will be familiarized with the high intensity intermittent exercise protocol to be used during the study days and will also be allowed to practice the cognitive and skill tests to be used (up to 8 times in order to remove any learning effect that may influence the results). During the third visit, baseline scores for the skill tests will be collected. Participants will perform 4 attempts (the first two will be for re-acclimation) and the last two will be recorded. The remaining two visits will be the study days and will be separated by at least 1 week. The order of treatments will be randomized to avoid any order effect. The night before study day, participants will arrive at the laboratory at 19:00 h and will be fed a standardized meal containing 2g/kg of carbohydrate (pasta and tomato sauce) and will not be allowed any food or drink except water thereafter. On the study day, participants will arrive to the lab at 07:30 h following an overnight 12h fast and will have refrained from exercise, caffeine or alcohol within the prior 24 hours. Baseline capillary blood lactate and blood glucose will be obtained by fingerprick by a trained phlebotomist. In order to ensure the prevention of infection and or contamination during sampling, standard sterile blood handling techniques will be used including the use of new medical examination gloves, alcohol swabs, and disposable sterile lancets. All blood-contaminated materials will be disposed of in a hazardous material labeled disposal (or sharps) container, promptly after analysis. Subsequently, baseline data for the cognitive tests will be collected. After collecting baseline data, the corresponding treatment will be given and 30 minutes after, participants will perform a standardized 10-minute warm-up, followed by the exercise session. The exercise session consists of a 60- minute simulated soccer game divided into 4 x 15-minute blocks exercising (running) at varying intensities that replicate the activity pattern of soccer such as sprinting, jogging, cruising, walking etc. The proportion of time spent at each speed will be allocated based on a time-motion analysis of professional soccer players observed by Reilly and Thomas (1976) as indicated by Clarke et al (2008). During each 15-minute block, cognitive function will be tested using the serial seven subtraction test and the Flanker test. Also, expired gas samples will be collected during the last 4 min of each standardized 15-minute block to estimate carbohydrate and fat oxidation. A fingerprick blood lactate and blood glucose sample will be collected at the end of each 15-minute block. Ratings of perceived exertion will also be taken at the end of each block. Water will be available ad-libitum during the first test day and will be quantified. The same amount of water will be provided for the remaining trial. After completion of the 60-minute simulated soccer game, we will test physical performance using a repeated sprint ability test comprised of twelve, 30m sprints with 35sec of walking recovery between each sprint. Subsequently, technical skills will be assessed using a battery test comprised of the Slalom Dribble test and the Loughborough Soccer Passing Test (LSPT). The Slalom Dribble test is a skill test that requires participants to dribble a soccer ball around a set obstacle course taking the least amount of time possible whereas the LSPT is a test that requires participants to accurately pass a soccer ball a set number of times towards coloured targets while negotiating a coned area, as quickly as possible.
- Being tested
- Superstarch, Placebo
- Keywords
- exercise, carbohydrate, Superstarch
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperstarchDietary supplement
Also called UCan
0.7 g Superstarch or placebo per kg body mass in two ingestions (before game \& at halftime)
PlaceboOther
0.7 g glucose per kg body mass in two ingestions (before game \& at halftime)
| Study group | Role | What they receive |
|---|---|---|
| Superstarch | Experimental | Supplementation with Superstarch before a simulated soccer game Receives: Dietary Supplement: Superstarch |
| Placebo | Placebo comparator | Supplementation with placebo before simulated soccer game. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in exercise performance
sprint run test (seconds); soccer skills (seconds), cognitive skills (seconds)
Measured: baseline; 60 minutes later (following soccer game)
Secondary outcomes (2)
change in blood glucose concentration
mmols/l
Measured: baseline; 60 minutes later
change in blood lactate concentration
mmols/l
Measured: baseline, 60 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Superstarch on Soccer PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Pete W Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667340
- Sponsor's protocol ID
- 10009797
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Starch Produced From Heat-treated Corn (Superstarch) Supplementation on Skills, Cognitive Function and Physical Performance During/Following a Simulated Soccer Game
- ClinicalTrials.gov ID
- NCT02667340
- Acronym / sponsor ID
- 10009797
- Keywords
- exercise, carbohydrate, Superstarch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of specific soccer skills, and on cognitive function during and following a simulated soccer game.
Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during the game with Generation UCAN vs isoenergetic placebo (glucose).
Detailed description
This will be a double blind cross over study. There will be two treatments involved: Superstarch and glucose (placebo). Participants and investigators will be blinded as an individual not involved in the project will prepare and distribute the treatment (drinks) according to a coding system that is kept confidential until the study is completed. Participants will complete each treatment once and the treatment order will be systematically rotated to avoid any order effect. Healthy men and women soccer players aged 18-35 yr will be recruited. Participants will come to the lab on five different occasions to complete two familiarization sessions, a baseline testing session, and two main trials. During the first visit, the participants will be asked to complete a physical activity readiness questionnaire (as approved previously; Par Q and a participant information form for personal and familial health history to rule out any pathologies or health issues that may preclude them from participating in the present study. Subsequently, the investigators will collect data for VO2max, body composition and sprinting speed. In the second visit, participants will be familiarized with the high intensity intermittent exercise protocol to be used during the study days and will also be allowed to practice the cognitive and skill tests to be used (up to 8 times in order to remove any learning effect that may influence the results). During the third visit, baseline scores for the skill tests will be collected. Participants will perform 4 attempts (the first two will be for re-acclimation) and the last two will be recorded. The remaining two visits will be the study days and will be separated by at least 1 week. The order of treatments will be randomized to avoid any order effect. The night before study day, participants will arrive at the laboratory at 19:00 h and will be fed a standardized meal containing 2g/kg of carbohydrate (pasta and tomato sauce) and will not be allowed any food or drink except water thereafter. On the study day, participants will arrive to the lab at 07:30 h following an overnight 12h fast and will have refrained from exercise, caffeine or alcohol within the prior 24 hours. Baseline capillary blood lactate and blood glucose will be obtained by fingerprick by a trained phlebotomist. In order to ensure the prevention of infection and or contamination during sampling, standard sterile blood handling techniques will be used including the use of new medical examination gloves, alcohol swabs, and disposable sterile lancets. All blood-contaminated materials will be disposed of in a hazardous material labeled disposal (or sharps) container, promptly after analysis. Subsequently, baseline data for the cognitive tests will be collected. After collecting baseline data, the corresponding treatment will be given and 30 minutes after, participants will perform a standardized 10-minute warm-up, followed by the exercise session. The exercise session consists of a 60- minute simulated soccer game divided into 4 x 15-minute blocks exercising (running) at varying intensities that replicate the activity pattern of soccer such as sprinting, jogging, cruising, walking etc. The proportion of time spent at each speed will be allocated based on a time-motion analysis of professional soccer players observed by Reilly and Thomas (1976) as indicated by Clarke et al (2008). During each 15-minute block, cognitive function will be tested using the serial seven subtraction test and the Flanker test. Also, expired gas samples will be collected during the last 4 min of each standardized 15-minute block to estimate carbohydrate and fat oxidation. A fingerprick blood lactate and blood glucose sample will be collected at the end of each 15-minute block. Ratings of perceived exertion will also be taken at the end of each block. Water will be available ad-libitum during the first test day and will be quantified. The same amount of water will be provided for the remaining trial. After completion of the 60-minute simulated soccer game, we will test physical performance using a repeated sprint ability test comprised of twelve, 30m sprints with 35sec of walking recovery between each sprint. Subsequently, technical skills will be assessed using a battery test comprised of the Slalom Dribble test and the Loughborough Soccer Passing Test (LSPT). The Slalom Dribble test is a skill test that requires participants to dribble a soccer ball around a set obstacle course taking the least amount of time possible whereas the LSPT is a test that requires participants to accurately pass a soccer ball a set number of times towards coloured targets while negotiating a coned area, as quickly as possible.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superstarch | Experimental | Dietary Supplement: SuperstarchSupplementation with Superstarch before a simulated soccer game |
| Placebo | Placebo comparator | Other: PlaceboSupplementation with placebo before simulated soccer game. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- healthy male and female elite soccer players who are involved in regular soccer training
- aged 15-35 years
Key exclusion criteria (5 listed)
- Smoker
- taking part in other research
- have a neurological or psychiatric condition that may cause cognitive dysfunction
- for women, if they are pregnant or become pregnant during the study
- Injury limiting exercise ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperstarchAlso: UCan0.7 g Superstarch or placebo per kg body mass in two ingestions (before game \& at halftime) | Dietary supplement | Superstarch |
| Placebo0.7 g glucose per kg body mass in two ingestions (before game \& at halftime) | Other | Placebo |
Primary outcome
change in exercise performance
Time frame: baseline; 60 minutes later (following soccer game)
sprint run test (seconds); soccer skills (seconds), cognitive skills (seconds)
2 secondary outcomes
change in blood glucose concentration
Time frame: baseline; 60 minutes later
change in blood lactate concentration
Time frame: baseline, 60 minutes later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pete W Lemon, PhD principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing Superstarch in people with Effect of Superstarch on Soccer Performance, run by University of Western Ontario, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pete w Lemon, PhD (519-661-2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in exercise performance (time frame: baseline; 60 minutes later (following soccer game)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.